地塞米松磷酸钠注射液的细菌内毒素检查  

Bacterial endotoxin test for dexamethasone sodium phosphate injection

作　　者：高岩 席时东 

机构地区：[1]浙江省宁波市药品检验所,浙江宁波315040

出　　处：《安徽医药》2007年第9期794-795,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的地塞米松磷酸钠注射液的细菌内毒素检查方法的建立。方法使用两个厂家、不同灵敏度的鲎试剂和两个厂家共6批地塞米松磷酸钠注射液进行干扰试验。结果地塞米松磷酸钠注射液浓度稀释至0.333 g.L-1时无干扰。结论地塞米松磷酸钠注射液可按内毒素限值6 Eu.mg-1进行细菌内毒素检查。Aim To establish the method of BET for dexamethasone sodium phosphate injection. Methods The interference test was conducted by using Limulus amebocyte lysate from 2 different factories and 6 samples from 2 factories. Results It was proved that the maximium noninterference concentration of dexamethasone sodium phosphate was 0. 333 g·L^-1. Conclusion The method of BET was suitable for dexamethasone sodium phosphate injection,and the bacterial endotoxin limit was 6 Eu·mg^-1.

关 键 词：鲎试剂 细菌内毒素 干扰试验 地塞米松磷酸钠注射液 

分 类 号：R927[医药卫生—药学]